Your session is about to expire
← Back to Search
Behavioral Intervention
Healthy Diet for High Blood Pressure (GoFresh Trial)
N/A
Recruiting
Led By Stephen P Juraschek, MD, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured 3 months after randomization
Awards & highlights
GoFresh Trial Summary
This trial is testing whether a healthy diet can lower blood pressure in adults who live in areas with limited access to fresh food.
Who is the study for?
This trial is for Black adults living in certain Boston areas without treated hypertension, with systolic blood pressure between 120-149 mm Hg and diastolic below 100 mm Hg. Participants must be able to receive and consume only provided groceries for 12 weeks, have kitchen facilities, Wi-Fi/cell service, and a device for grocery orders. Exclusions include severe health conditions like diabetes or recent cardiovascular events, significant weight changes recently, extreme diets or food insecurities.Check my eligibility
What is being tested?
The GoFresh trial is examining if home-delivered DASH-patterned groceries can lower blood pressure among Black adults in urban food deserts of Boston. It's a randomized study where some will get dietitian-assisted shopping while others will shop on their own.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include initial discomfort adjusting to new foods or patterns of eating but are not expected to be severe.
GoFresh Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured 3 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured 3 months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seated, office-based, systolic blood pressure (intervention phase)
Secondary outcome measures
24-hour dietary recall (intervention & observation phases)
24-hour urine potassium (intervention & observation phases)
24-hour urine sodium (intervention & observation phases)
+9 moreOther outcome measures
Grocery shopping and dining habits
Perceived Stress Scale 4 (PSS-4)
Qualitative Interviews
+1 moreGoFresh Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dietitian-Assisted DASH groceriesExperimental Treatment1 Intervention
Participants will order groceries sufficient to meet their caloric needs each week for 12 weeks with the assistance of a dietitian/nutrition interventionist. Groceries will be delivered to participants' homes or picked up at a convenient location. The dietitian/nutrition interventionist will provide brief educational content at the time of food delivery. Orders will be placed via phone or through virtual counseling sessions. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries.
Group II: Self-directed shopping (referent assignment)Active Control1 Intervention
Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,080 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,680 Total Patients Enrolled
Stephen P Juraschek, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost or gained more than 5% of my weight in the last 2 months.I am not taking potassium supplements, warfarin, chronic steroids, or weight loss drugs.I haven't had cancer treatment in the last 2 years, except for certain localized cancers.I can get groceries delivered or pick them up and will only eat these for 12 weeks.My family has more than 6 adults at dinner, counting kids as half.I have not had any major heart issues or strokes in the last 6 months.My medication doses for conditions like diabetes, asthma, COPD, hormone issues, or mental health have been stable for the last 2 months.I have food allergies or dietary needs that may affect my diet adherence.I have had recent issues with my digestive system, including surgery or inflammation.I am currently in or planning to start a weight loss program.I have diabetes with an A1c level of 6.5% or higher, or I am on diabetes treatment.I have visited the ER for asthma or COPD in the past 6 months.I have taken blood pressure or hypertension medication in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Dietitian-Assisted DASH groceries
- Group 2: Self-directed shopping (referent assignment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial still accept participants?
"This clinical trial, which was first made available on August 15th 2022 is currently recruiting participants. The data posted to the site has been updated as recently as August 11th of this year."
Answered by AI
Are individuals aged 75 or greater being invited to join this research?
"This clinical trial is open to those aged 18 and over, with a cap of 100 years old set for enrollment."
Answered by AI
How many individuals have elected to participate in this experiment?
"Affirmative. The clinical trial posted on August 15th 2022 is currently recruiting patients, and was most recently revised on August 11th 2022. 150 people are needed to participate between the two designated locations."
Answered by AI
Are there any eligibility criteria for participation in this clinical trial?
"This medical study is recruiting 150 individuals suffering from hypertension aged between 18 and 100 years old. Notably, candidates should be self-identified Black or African Americans living in Massachusetts' food deserts; have a systolic blood pressure of 120 to <150 mm Hg and diastolic pressure of <100 mm Hg; possess serum potassium ≥5.0 mmol/L or <3.5 mmol/L; have an eGFR below 30 mL/min per 1.73 m^2 by the CKD-EPI equation; exhibit Hemoglobin A1c levels above 6.5%; agree to receive home delivered groceries over"
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger